Trial · NCT03711279
A Study of SHR-1210 Plus Apatinib in Patients With Soft Tissue Sarcoma
NCT03711279, Phase 2, Terminated, Jiangsu HengRui Medicine Co., Ltd.; results first posted 2024-02-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of SHR-1210 Plus Apatinib in Patients With Soft Tissue Sarcoma. Trials, record NCT03711279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03711279
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of SHR-1210 Plus Apatinib in Patients With Soft Tissue Sarcoma
- NCT number
- NCT03711279
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 99 participants, actual
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Conditions
- Sarcoma
- Interventions
- SHR-1210 plus Apatinib, ADM plus IFO or IFO alone
- First posted
- 2018-10-18
- Last updated
- 2024-02-29
- Results first posted
- 2024-02-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. | Randomization to Radiographic Progression or Death Due to Any Cause (Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions) |
| Secondary | Objective Response Rate (ORR) | From date of randomization until the date of study completion, an average of 1 year, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. | Baseline to documented disease Remission to study discontinuation, Partial Remission is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 30% decrease in the sum of the beaseline diameter of target lesions. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. | months | MEDIAN | |
| SECONDARY | Objective Response Rate (ORR) | From date of randomization until the date of study completion, an average of 1 year, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | SHR-1210 Plus Apatinib | 5.6 | 95% Confidence Interval 4.1 to 6.9 | months | |
| Progression Free Survival (PFS) | ADM Plus IFO or IFO Alone | 5.5 | 95% Confidence Interval 3.5 to 8.4 | months | |
| Objective Response Rate (ORR) | SHR-1210 Plus Apatinib | 11 | participants | ||
| Objective Response Rate (ORR) | ADM Plus IFO or IFO Alone | 5 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SHR-1210 Plus Apatinib | 51 | |
| Overall Study | STARTED | ADM Plus IFO or IFO Alone | 48 | |
| Overall Study | COMPLETED | SHR-1210 Plus Apatinib | 50 | |
| Overall Study | COMPLETED | ADM Plus IFO or IFO Alone | 47 | |
| Overall Study | NOT COMPLETED | SHR-1210 Plus Apatinib | 1 | |
| Overall Study | NOT COMPLETED | ADM Plus IFO or IFO Alone | 1 |
Source ClinicalTrials.gov
Adverse events276
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | SHR-1210 Plus Apatinib | 21 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | ADM Plus IFO or IFO Alone | 34 | 47 | |
| other | Coagulopathy | Blood and lymphatic system disorders | SHR-1210 Plus Apatinib | 3 | 50 | |
| other | Coagulopathy | Blood and lymphatic system disorders | ADM Plus IFO or IFO Alone | 0 | 47 | |
| other | Sinus tachycardia | Cardiac disorders | SHR-1210 Plus Apatinib | 8 | 50 | |
| other | Sinus tachycardia | Cardiac disorders | ADM Plus IFO or IFO Alone | 0 | 47 | |
| other | Hypothyroidism | Endocrine disorders | SHR-1210 Plus Apatinib | 20 | 50 | |
| other | Hypothyroidism | Endocrine disorders | ADM Plus IFO or IFO Alone | 1 | 47 | |
| other | Hyperthyroidism | Endocrine disorders | SHR-1210 Plus Apatinib | 8 | 50 | |
| other | Hyperthyroidism | Endocrine disorders | ADM Plus IFO or IFO Alone | 0 | 47 |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SHR-1210 Plus Apatinib | 2 | 50 |
| Total, all-cause mortality | ADM Plus IFO or IFO Alone | 2 | 47 |
| Total, other adverse events | SHR-1210 Plus Apatinib | 50 | 50 |
| Total, other adverse events | ADM Plus IFO or IFO Alone | 45 | 47 |
| Total, serious adverse events | SHR-1210 Plus Apatinib | 27 | 50 |
| Total, serious adverse events | ADM Plus IFO or IFO Alone | 13 | 47 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SHR-1210 Plus Apatinib vs ADM Plus IFO or IFO Alone: Objective Response Rate (ORR) | Trial comparisons |
| SHR-1210 Plus Apatinib vs ADM Plus IFO or IFO Alone: deaths from any cause | Trial comparisons |
| SHR-1210 Plus Apatinib vs ADM Plus IFO or IFO Alone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03711279
GET https://conductscience.org/api/trials/v1/NCT03711279/events?page=2